Scalp Study

Understanding the Effects of Hyper Shampoo on Skin

Summary of Results:

The objective of this human repeat insult patch test was to assess whether the test substance, Hyper Shampoo (Batch: F#033121CR1), induces contact irritation or sensitization through repetitive applications on the skin of healthy volunteers.

The study was conducted in compliance with the recommendations of the Helsinki Declaration and the "Guidelines for the Assessment of Skin Tolerance of Potentially Irritant Cosmetic Ingredients" set by COLIPA in 1997. An independent ethics committee reviewed and approved the trial protocol to ensure the protection and well-being of human subjects.

Healthy volunteers (51 participants out of 58) were recruited according to strict inclusion criteria. The study consisted of three phases: Induction Phase, Rest Phase, and Challenge Phase.

In the Induction Phase, the test substance was applied to the skin three days a week for three consecutive weeks. The product's concentration was diluted to 1%, and occlusive patches were used. The application area was evaluated for reactions, including erythema, desquamation, edema, and vesicles. No adverse events were reported during this phase.

During the Rest Phase, no products were applied to allow for a recovery period.

In the Challenge Phase, a retest/challenge patch containing the test substance was applied once to an unpatched test site. The test site was evaluated 48 hours after application. Again, no adverse events were reported.

The results indicated that under the exposure conditions of the test, Hyper Shampoo Batch: F#033121CR1 was considered a non-primary irritant, a non-primary sensitizer, and hypoallergenic to the skin.

Detailed Summary:

The study aimed to determine if Hyper Shampoo (Batch: F#033121CR1) could induce contact irritation or sensitization on the skin of healthy volunteers through repetitive applications. The test substance was diluted to 1% with demineralized water and applied using adhesive strips in occlusive patches.

The study was conducted in compliance with ethical guidelines, and healthy volunteers were recruited based on strict inclusion and exclusion criteria. The volunteers underwent an informed consent process and were informed about the study's purpose and potential risks.

The study consisted of three phases:

  1. Induction Phase: The test substance was applied three days a week for three consecutive weeks. The application area was evaluated for reactions such as erythema, desquamation, edema, and vesicles. No adverse events were reported during this phase.
  2. Rest Phase: Volunteers had a 10-14 days rest period with no product application.
  3. Challenge Phase: A retest/challenge patch was applied to an unpatched site, and the area was evaluated 48 hours after application. No adverse events were reported.

    Based on the obtained results, Hyper Shampoo Batch: F#033121CR1 was considered a non-primary irritant, a non-primary sensitizer, and hypoallergenic to the skin. The study findings were supervised by a dermatologist and verified by independent professionals involved in the study.

    The full report, including study protocol, raw data, and final conclusions is available here: Study PDF